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news.Company to submit a protocol to FDA containing the proposed trial design in July 2009
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Anadys has declared a strategic restructuring to focus its operations on the development of Ana598, in particular a proposed Phase II study in hepatitis C patients of Ana598 in combination with pegylated interferon-alpha and ribavirin.
The company said that it is now intending to submit a protocol to the FDA containing the proposed trial design in July 2009. Anadys intends to initiate the trial during the third quarter of 2009.
Steve Worland, President and CEO of Anadys, said: We have now completed three Phase I studies of ANA598 and we have seen potent antiviral activity, as well as good tolerability.
As we complete preparations for the first Phase II study of ANA598 in combination with interferon and ribavirin, we have decided to focus our future investments on this important asset and to take these cost-sparing measures which we expect to ensure our ability to complete the Phase II study with our expected cash resources. The proposed Phase II study is expected to provide important data at the end of this year and in the first two quarters of 2010, he added.